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Exercise + Multivitamin Supplement for Myotonic Dystrophy (DM1HBET Trial)
Phase 3
Waitlist Available
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months from enrolment
Awards & highlights
Pivotal Trial
Summary
This trial is investigating if exercise and a multivitamin supplement can help people with a genetic muscle disease called "Myotonic dystrophy type 1" (DM1) to improve their symptoms and quality of life.
Who is the study for?
This trial is for men and women aged 19-60 with Myotonic Dystrophy type 1 (DM1), having CTG repeats between 100-1000. Participants should have a BMI of 18.5-29.9, be physically inactive, and able to walk between 250-500 meters in six minutes without severe heart rhythm abnormalities.
What is being tested?
The study tests if a home-based exercise program combined with either a multi-ingredient supplement or placebo can improve muscle function and body composition in DM1 patients over the course of 16 weeks.
What are the potential side effects?
Potential side effects may include typical exercise-related issues like muscle soreness or strain. The multi-ingredient supplement could cause digestive discomfort or allergic reactions, depending on its contents.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 months from enrolment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months from enrolment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Body Composition Index
VO2 Max
Secondary study objectives
5x sit to stand
6-minute walk test
Grip strength
+5 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
3Treatment groups
Active Control
Placebo Group
Group I: DM1 + HBEXT + MISActive Control2 Interventions
Participants will be asked to undergo 16 weeks of home-based training and asked to take one dose of a multi-ingredient supplement per day.
Group II: CONTROLActive Control1 Intervention
Healthy control subjects who will not undergo study intervention and will be used for baseline measurements and outcomes.
Group III: DM1 + HBEXT + PLAPlacebo Group2 Interventions
Participants will be asked to undergo 16 weeks of home-based training and asked to take one dose of a multi-ingredient supplement placebo per day.
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Who is running the clinical trial?
McMaster UniversityLead Sponsor
917 Previous Clinical Trials
2,616,294 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My BMI is over 30.I am between 19 and 60 years old and have been diagnosed with DM1.I need more than 2 medications to manage my high blood pressure.I have diabetes and take more than one medication for it.I have not had a heart attack in the last 6 months.My genetic test shows I have 100-1000 CTG repeats.I have severe nerve pain or numbness in my hands or feet.I use painkillers or anti-inflammatory drugs.I can walk less than 250 meters in 6 minutes for more than 2 weeks.I have severe osteoporosis.I use more than two medications for my asthma.I am not taking medications like corticosteroids that affect protein metabolism.I am a healthy man or woman.I have severe joint pain or active injuries in my muscles or bones.I have a heart block.My kidney function is normal.I take multiple medications for my heart failure.I had a stroke and still have weakness on one side of my body.I have lost a lot of weight in the last 3 months.I have a lung condition that limits my breathing capacity.I can walk between 250 to 500 meters in 6 minutes.I have a known liver condition.I am able to understand and consent to my treatment.
Research Study Groups:
This trial has the following groups:- Group 1: DM1 + HBEXT + PLA
- Group 2: DM1 + HBEXT + MIS
- Group 3: CONTROL
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.